Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes for the Treatment of Advanced Breast Cancer

Exclusion Criteria

• •Patients with any of the following criteria will not be allowed to participation:
• •1. Test subjects who have a history of hypersensitivity to any component or excipient of HS-IT101 or other study drugs (cyclophosphamide, fludarabine and recombinant human interleukin-2);
• •2. Test subjects have any uncontrollable clinical problems (including but not limited):
• •* hypertension poorly controlled by medication (blood pressure ≥150/90mmHg at rest after taking medication);
• •* poorly controlled diabetes;
• •* cardiac disease (New York Heart Association class Ⅲ/Ⅳ congestive heart failure or heart block);
• •3. Test subjects who have active major medical illnesse(es) of the cardiovascular (within 6 months prior to enrollment), including deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient cerebral ischemia Seizures, cerebral embolism;
• •4. Active autoimmune diseases or recipients of organ transplants that require systemic treatment during the study period, or a history of such diseases within the past 2 years;
• •5. Prior used any immunosuppressive medications, such as corticosteroids (within 14 days prior to enrollment); physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent) are permitted, as well as inhaled, intranasal, or topical corticosteroids;
• •6. Test subjects with symptomatic and/or untreated brain metastases;
• •7. Current or prior use of anticancer therapy: a.) chemotherapy, immune checkpoint inhibitor, other investigational therapy drug or local treatment for target lesions within the past 4 weeks; b.) chinese patent medicine with anti-tumor indications, or systemic therapy with immunomodulatory drugs (including thymosin, interferon, drugs targeting) within the past 2 weeks; c.) targeted drug therapy within the past 4 weeks or 5 half-lives, whichever is shorter;
• •8. Presence of acute or chronic infection:
• •* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive;
• •* Active TB infection;
• •* Active bacterial or fungal infection requiring systemic treatment;
• •* HBsAg and/or HBeAg positive;
• •* Hepatitis C patients;
• •* Treponema pallidum antibodies positive;
• •9. Vaccinated with the new coronavirus vaccine within 14 days propr to screening, or who have received a live vaccine within 3 months, or who plan to receive live vaccine during the trial;
• •10. Major organs underwent surgery (excluding needle biopsy) or significant trauma within 4 weeks before screening；required elective surgery during the study;
• •11. Test subjects who have had another primary malignancy within the previous 5 years, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after radical resection;
• •12. Females in pregnancy or lactation;
• •13. Test subjects have had SAE requiring blood product support occurred in previous chemotherapy, including but not limited to whole blood, red blood cells, platelets;
• •14. Subject have mental illness, alcoholism, drug or substance abuse；or researchers considering the test subject as having other reasons inappropriate for the clinical study.